Anterior Myocardial InfarctionPiCSO-STEMINCT05644925
Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
A study testing PiCSO Impulse System and Percutaneous Coronary Intervention (PCI) in people with Anterior Myocardial Infarction, run by Fundacio Privada Mon Clinic Barcelona.
Trial summary
In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Myocardial Infarction
- What is being tested?
- PiCSO Impulse System and Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2022to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
- Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
- Pre-PCI TIMI flow 0-1.
- Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
- The patient is eligible for primary PCI.
- Informed consent received and signed for study enrollment.
Who cannot join
- Contraindication to coronary angiogram or PCI.
- Implants or foreign bodies in the coronary sinus.
- Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
- Known pregnancy or breastfeeding.
- Known coagulopathy.
- Known severe kidney disease (eGFR <=30 mL/min/1.73) and/or hemodialysis.
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- Known large pericardial effusion or cardiac tamponade.
- Central hemodynamically relevant left-right shunt.
- Previous MI or Coronary Artery Bypass Graft (CABG).
- Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
- Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
- Unconscious at presentation.
- Need for circulatory support.
- Need for invasive mechanical ventilation.
- Need for temporal intravenous pacemaker.
- Patient not suitable for femoral access.
- Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
- Known epicardial stenosis greater than 50% distal to the culprit LAD lesion.
- Active participation in another drug or device investigational trial.
- Medical, social or psychological condition that limits the ability of patient to participate in the study.
- Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.
About this study
In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.
- Conditions
- Anterior Myocardial Infarction
- Being tested
- PiCSO Impulse System, Percutaneous Coronary Intervention (PCI)
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCSO Impulse SystemDevice
The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
Minimally invasive procedures used to open clogged coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| PICSO+PCI | Experimental | Not described Receives: Device: PiCSO Impulse System; Procedure: Percutaneous Coronary Intervention (PCI) |
| Standard PCI | Active comparator | Not described Receives: Procedure: Percutaneous Coronary Intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of PiCSO in reducing microvascular dysfunction
To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance >500 WU) as compared to standard of care
Measured: After primary PCI at time 0 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start14 Nov 2022
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Why it stopped: Lack of financial support for recruitment and follow-up activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized (1:1) to PiCSO group or standard PCI control group. Once randomized, PiCSO group patients will receive PiCSO therapy inside the catheterization laboratory.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Privada Mon Clinic Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Miracor Medical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644925
- Sponsor's protocol ID
- PiCSO-STEMI
- Acronym
- PiCSO-STEMI
- Status last verified
- Aug 2025
- First submitted
- 30 Nov 2022
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL
- ClinicalTrials.gov ID
- NCT05644925
- Acronym / sponsor ID
- PiCSO-STEMI / PiCSO-STEMI
- Conditions
- Anterior Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support for recruitment and follow-up activities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacio Privada Mon Clinic BarcelonaUniversity, hospital or other
- Collaborators
- Miracor Medical SA
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized (1:1) to PiCSO group or standard PCI control group. Once randomized, PiCSO group patients will receive PiCSO therapy inside the catheterization laboratory.
| Arm | Type | Receives |
|---|---|---|
| PICSO+PCI | Experimental | Device: PiCSO Impulse System, Procedure: Percutaneous Coronary Intervention (PCI) |
| Standard PCI | Active comparator | Procedure: Percutaneous Coronary Intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old.
- Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
- Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
- Pre-PCI TIMI flow 0-1.
- Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
Key exclusion criteria (21 listed)
- Contraindication to coronary angiogram or PCI.
- Implants or foreign bodies in the coronary sinus.
- Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
- Known pregnancy or breastfeeding.
- Known coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCSO Impulse SystemThe PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1. | Device | PICSO+PCI |
| Percutaneous Coronary Intervention (PCI)Minimally invasive procedures used to open clogged coronary arteries | Procedure or surgery | PICSO+PCI, Standard PCI |
Primary outcome
Superiority of PiCSO in reducing microvascular dysfunction
Time frame: After primary PCI at time 0 after intervention
To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance >500 WU) as compared to standard of care
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PiCSO Impulse System and Percutaneous Coronary Intervention (PCI) in people with Anterior Myocardial Infarction, run by Fundacio Privada Mon Clinic Barcelona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of PiCSO in reducing microvascular dysfunction (time frame: After primary PCI at time 0 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.